Between December 2013 and November 2014, 428 patients in France received ibrutinib, which had been granted temporary Authorization for Use (ATU) by the French National Agency for Medicines and Health Product Safety (ANSM). In the current study, the characteristics and outcomes of 71 patients aged over 75 are reported; data was collected from medical records and inputted into electronic case report forms by primary care physicians.

Del(17p)/TP53 mutations were found to have a smaller impact on PFS and DoR than comorbidities had (HR = 0.827, P = 0.683; HR = 0.631; P = 0.543)

The authors concluded that their analysis of very elderly patients, the oldest cohort ever reported outside clinical trials, “supports the use of ibrutinib” in these patients. Treatment with ibrutinib was efficacious, but does require management of toxicities. However, decreasing the dose of ibrutinib did not negatively affect clinical outcomes, indicating dose reduction is a suitable strategy.

Abstract:

Expert Opinion

This is an observational study in 71 very old patients (many of them over 80 years) with highly pre-treated, relapsed or refractory CLL. All patients had ibrutinib as salvage treatment. Outcome data are favorable.

This report is of note as 80+ year old patients treated with ibrutinib were highly underrepresented in past ibrutinib trials as well as in the real-word ibrutinib cohorts published so far. In fact, this is the largest study cohort of that age group published in the context of ibrutinib treatment.

Results provide a rationale to not withhold ibrutinib salvage from patients with relapsed/refractory CLL just because of an age of 80+ years.

May 18, 2017

Jan 3, 2017

Professional society

The European Lymphoma Institute is comprised of a network of top European specialists in the field of lymphoma who are dedicated to research, training and education. Together they look to define strategies to analyse and characterize lymphoma and its common diagnostic procedures and therapeutic standards, as well as to facilitate clinical and fundamental research. This all results in the advancement of lymphoma research and it guarantees equal access for all patients to the best possible care.